- Up to 50% of patients with ER+/HER2- mBC could develop ESR1 mutations as a result of prior exposure to endocrine therapy in the metastatic setting. Testing to identify these mutations can help clinicians support more informed treatment-making decisions.
- The Next platform will analyze clinical data from mBC patients treated in certain centers and notify clinicians when ESR1 testing is missing at disease progression.
CHICAGO and NEW YORK, Feb. 21, 2025 (GLOBE NEWSWIRE) -- Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, and the Menarini Group ("Menarini"), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics, Inc. ("Stemline"), a wholly-owned subsidiary of the Menarini Group focused on bringing transformational oncology treatments to cancer patients, today announced a new collaboration. The two companies will leverage Next – Tempus’ AI-enabled care pathway intelligence platform – to help clinicians determine when an ESR1 test may be appropriate.
Up to 50% of patients with ER+/HER2- mBC could develop ESR1 mutations as a result of prior exposure to endocrine therapy in the metastatic setting.i Recognizing the clinical importance of these mutations, the American Society of Clinical Oncology (ASCO) updated its guidelines to recommend ESR1 mutation testing at each mBC disease progression. ii ESR1 mutations are subclonal and heterogeneous within the tumor; therefore, testing for ESR1 with a tissue biopsy may not identify these mutations. Instead, the guidelines recommend clinicians should test for ESR1 mutations using liquid biopsy due to its greater sensitivity and ability to show a markedly higher prevalence of any of the genomic alterations assessed. iii,iv Unlike testing for other biomarkers, using an archived tumor tissue sample taken before disease progression on first-line treatment in mBC is not recommended. ESR1 testing via liquid biopsy can help clinicians understand what is driving the breast cancer’s progression, and in turn, support more informed treatment-making decisions.
Tempus’ Next platform will analyze clinical data from mBC patients treated in certain centers and notify clinicians when ESR1 testing is missing at disease progression. By providing these timely notifications directly into the physicians’ workflow, Next helps support the appropriate integration of this critical step into the patient’s treatment journey in an effort to optimize care and potential outcomes.
“This collaboration is the first time we are applying Tempus Next to address a critical care gap in breast cancer, leveraging AI to support physicians in delivering recent guideline recommendations for this specific patient population,” said Chris Scotto DiVetta, Senior Vice President, AI Applications at Tempus. “We have just begun to demonstrate the potential Next can have in helping physicians deliver the most up-to-date, guideline-recommended care for their patients across a number of indications, and we look forward to making that a reality for patients with metastatic breast cancer.”
“We are thrilled to enter this collaboration with Tempus, a leader in leveraging AI to advance precision medicine and patient care. ESR1 mutations can stop tumors from responding to standard endocrine therapy, in turn causing the cancer to progress. With an approved treatment that targets these mutations, the identification of ESR1 is a critical step in customizing care for patients with ER+, HER2- metastatic breast cancer,” said Yasir Nagarwala, Senior Vice President, Medical Affairs, Stemline Therapeutics, Inc. “At Menarini Stemline, we are focused on bringing transformational therapies to patients living with cancer, and by partnering with companies like Tempus, we are able to help physicians understand when testing for an ESR1 mutation may be appropriate.”
Tempus Next is an AI-powered platform that leverages data to identify the right patient for the right next step in their care. To learn more about Tempus Next, visit tempus.com.
About Tempus
Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.
About The Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4.7 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit menarini.com.
About Stemline Therapeutics, Inc.
Stemline Therapeutics, Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on bringing transformational oncology treatments to patients. Stemline commercializes elacestrant, an oral endocrine therapy indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy, in the U.S., Europe, and other global regions. Stemline also commercializes tagraxofusp-erzs, a novel targeted therapy directed to CD123, for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), an aggressive hematologic cancer, in the United States, Europe, and other global regions. In addition, Stemline commercializes selinexor, an XPO1 inhibitor for multiple myeloma, in Europe. The company is also conducting multiple label-expansion studies with elacestrant and tagraxofusp in breast and hematologic cancer indications, respectively, and has an extensive clinical pipeline of additional drug candidates in various stages of development for a host of solid and hematologic cancers.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended, about Tempus and Tempus’ industry that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this press release are forward-looking statements, including, but not limited to, statements regarding the expected outcomes and benefits of the collaboration with Stemline, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “going to,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” or the negative of these words or other similar terms or expressions. Tempus cautions you that the foregoing may not include all of the forward-looking statements made in this press release.
You should not rely on forward-looking statements as predictions of future events. Tempus has based the forward-looking statements contained in this press release primarily on its current expectations and projections about future events and trends that it believes may affect Tempus’ business, financial condition, results of operations and prospects. These forward-looking statements are subject to risks and uncertainties related to: Tempus’ financial performance; the ability to attract and retain customers and partners; managing Tempus’ growth and future expenses; competition and new market entrants; compliance with new laws, regulations and executive actions, including any evolving regulations in the artificial intelligence space; the ability to maintain, protect and enhance Tempus’ intellectual property; the ability to attract and retain qualified team members and key personnel; the ability to repay or refinance outstanding debt, or to access additional financing; future acquisitions, divestitures or investments; the potential adverse impact of climate change, natural disasters, health epidemics, macroeconomic conditions, and war or other armed conflict, as well as risks, uncertainties, and other factors described in the section titled “Risk Factors” in Tempus’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 filed with the Securities and Exchange Commission (“SEC”) as well as in other filings Tempus may make with the SEC in the future. In addition, any forward-looking statements contained in this press release are based on assumptions that Tempus believes to be reasonable as of this date. Tempus undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of this press release or to reflect new information or the occurrence of unanticipated events, except as required by law.
Media Contacts
Tempus AI, Inc.
Erin Carron
Email: media@tempus.com
The Menarini Group
Valeria Speroni Cardi
Email: pressoffice@menarini.com
Stemline Therapeutics, Inc.
Cheya Pope
Email: media@menarinistemline.com
i Zundelevich A, et al. Breast Cancer Res 2020;22(1):16
ii Burstein, Harold J., et al. “Testing for ESR1 mutations to guide therapy for hormone receptor–positive, human epidermal growth factor receptor 2–negative metastatic breast cancer: ASCO guideline rapid recommendation update.” Journal of Clinical Oncology, vol. 41, no. 18, 2023.
iii Brett JO, Spring LM, Bardia A, Wander SA. ESR1 mutation as an emerging clinical biomarker in metastatic hormone receptor-positive breast cancer. Breast Cancer Res. 2021;23(1).
iv Turner NC, Kingston B, Kilburn LS, et al: Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): A multicentre, multicohort, phase 2a, platform trial. Lancet Oncol 21:1296-1308, 2020
